**Policy Summary:**
To address the surge in COVID-19 cases and the need for increased vaccine availability in India, the Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a modification to its earlier notice dated April 15, 2021 (Reference Number X11026072020PRO). Based on the recommendation of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), COVID-19 vaccines already approved for restricted use by regulatory agencies such as the US FDA, EMA, UK MHRA, Japan, or listed in the WHO Emergency Use Listing (EUL) are eligible for approval for restricted use in India. This modification exempts these vaccines from bridging clinical trials and the requirement of batch testing at the Central Drugs Laboratory (CDL), Kasauli, provided the vaccine batch has been certified and released by the National Control Laboratory of the country of origin. However, the CDL Kasauli will still undertake Summary Lot Protocol review and Certificate of Analysis for batch release, as per established guidelines, before the vaccine can be included in the national immunization program. The policy aims to expedite the approval process for imported COVID-19 vaccines to meet national requirements, even as domestic manufacturing capacity increases.
Key Entities Referenced
Directorate General of Health Services: An agency of the Government of India responsible for public health.
Central Drugs Standard Control Organization: National Regulatory Authority responsible for regulating pharmaceuticals and medical devices in India.
COVID19: The disease caused by the SARS-CoV-2 virus, which triggered a global pandemic.
NEGVAC: National Expert Group on Vaccine Administration for COVID-19, an expert group in India advising on COVID-19 vaccine strategy.
US FDA: United States Food and Drug Administration, a federal agency responsible for regulating food and drug products in the USA.
EMA: European Medicines Agency, a medicines regulator of the European Union.
UK MHRA: Medicines and Healthcare products Regulatory Agency of the United Kingdom.
WHO Emergency Use Listing EUL: A procedure used by the World Health Organization (WHO) to assess and list unlicensed vaccines, therapeutics and in vitro diagnostics during public health emergencies.
Central Drugs Laboratory CDL, Kasauli, Himachal Pradesh: A national control laboratory in India responsible for testing and batch release of vaccines.
X-11026/07/2020-PRO
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Public Relation Office)
In light of the huge vaccination requirements in India in the wake of the recent
surge of COVID-19 cases and the need for increased availability of imported vaccines
to meet the national requirements even though the domestic manufacturing of COVID-
19 vaccines is getting augmented, in partial modification of this office Notice of even
number dated 15.04.21, as per recommendation of NEGVAC, it has been decided
that for approval of COVID-19 Vaccines in India for restricted use in
on which are already approved for restricted use by US FDA, EMA, UK MHRA,
Japan or which are listed in WHO Emergency Use Listing (EUL) and which
Bere. acces fom te ane Pe ee ee
oval b clinical trials and the requirement of testing of every batch of the
‘the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine
has been certified and released by National Control Laboratory of Country of
review of their Summary Lot Protocol & Certificate of analysis of
Jertaken by CDL Kasauli for Batch release as per the standard
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